Acute Pain Clinical Trial
Official title:
Safety and Speed of Onset of a Fixed Dose of Intravenous Hydromorphone in the Treatment of Adult Patients Presenting to the Emergency Department With Acute Severe Pain
The purpose of this study is to determine the safety and speed of onset of 2mg intravenous hydromorphone (Dilaudid) in patients weighing at least 150 lbs presenting to the emergency department with acute severe pain
Introduction and Background: Pain is cited as the most frequent reason for visits to
emergency departments (EDs) (McCaig, 2001). It can be estimated from the National Hospital
Ambulatory Medical Care Survey, an annual survey of a representative sample of visits to US
EDs, that there are 17 million visits per year to US EDs for specific complaints of pain, 29
million visits including "back symptoms" and "injuries not otherwise specified" as well as
specific mentions of pain. However it is widely acknowledged that pain is seriously
under-treated in the ED as well as in other health care settings (Ducharme, 1996; Selbst,
1990; Wilson, 1989). The concern regarding under-treatment is reflected in new standards for
pain management developed by the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) requiring assessment of pain at triage in the ED and referring to pain
measurement as the "fifth vital sign" (Philips, 2000).
Proper pain management is a tremendous challenge to ED physicians as pain is not only a
noxious experience but also a symptom of injury and disease that needs to be understood and
appropriately treated. Further complicating pain management is the large interpersonal
variability in pain perception and expression reflecting cultural, contextual, and individual
differences between people. Reasons for under-treating pain include concern over side effects
of opioids, perception of pain complaints as possible drug-seeking behavior, under-staffing,
concern that analgesics will mask symptoms or delay early diagnosis and treatment, and
contribute to risks of tolerance and dependence in vulnerable patients.
Morphine has long been considered the gold standard in pain control. Hydromorphone is another
powerful opioid that has been used extensively for the management of post-operative pain and
morphine-resistant cancer-related pain. A recent Cochrane review on the use of hydromorphone
found 32 studies that focused on acute pain (Quigley, 2003). Of these 32 studies, only 9
involved intravenous forms of hydromorphone (Coda, 1997; Collins, 1996; Deutsch, 1968;
Jasani, 1994; Liu, 1995; Mahler, 1975; Rapp, 1996; Searle, 1994; Urquhart, 1988). Of these 8
studies, 5 involved patient controlled analgesia, and only 1 study compared IV hydromorphone
to IV morphine (Mahler, 1975). The Cochrane review concludes that there are substantial gaps
in the understanding of the efficacy and potency of hydromorphone.
We have recently completed a study in non-elderly adult patients (IRB 04-08-225) that showed
that weight-based IV hydromorphone provides better pain relief than weight-based IV morphine.
This result was both statistically and clinically significant. We also demonstrated in this
same study that IV hydromorphone has a faster onset and also provided statistically
significant improvement in pain relief at 5 minutes as compared to IV morphine.
Although weight-based dosing of medications is common in pediatrics, most emergency
physicians use whole integer amounts of pain medications. IV hydromorphone is more potent
than IV morphine, so the dosages given are much smaller. We therefore wish to give a standard
2 mg dose of IV hydromorphone to all non-elderly adult patients weighing at least 150 lbs
presenting to the ED with acute severe pain. We wish to examine the safety and speed of onset
of hydromorphone using such a protocol.
Our general thought is that to develop more evidence based practice, we need to generate more
practice based evidence. This study attempts to do this as it is practiced based and very
practical. We wish to take the drug as it comes (2mg Dilaudid in an ampule) and use all of
it, thus alleviating the need to waste the excess opioid (and alleviating the need to find a
second person to witness the wasting). We also wish to use a weight cutoff that everyone can
remember (150 lbs). We believe that this protocol will provide greater pain relief and help
address the issue of inadequate pain treatment, or "oligoanalgesia", that is prominent in the
literature (Sobel 2002, Wilson, 1989, Goldfrank 2000).
Finally, in our multiple studies of pain conducted in the ED, we have found a relatively high
rate of refusal to receive pain medication. We think this may represent a component to the
problem of oligoanalgesia that is widespread in the ED. We wish to investigate the reasons
for patient refusal to receiving parental opioid medications (fear of addiction, side
effects, etc).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04484610 -
Appropriate Opioid Quantities for Acute Pain - Pharmacist Study
|
Phase 4 | |
Recruiting |
NCT05054179 -
Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04548635 -
VR for Burn Dressing Changes at Home
|
Phase 2/Phase 3 | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Completed |
NCT06054945 -
Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
|
||
Completed |
NCT03825549 -
A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing
|
N/A | |
Completed |
NCT05995912 -
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
|
Phase 2 | |
Recruiting |
NCT05589246 -
Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure
|
N/A | |
Recruiting |
NCT05572190 -
Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects
|
Phase 1 | |
Terminated |
NCT04716413 -
Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
|
Phase 4 | |
Active, not recruiting |
NCT03537573 -
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
|
N/A | |
Not yet recruiting |
NCT06317844 -
Examination of Psychological and Physiological Pathways Linking Gratitude and Pain
|
N/A | |
Withdrawn |
NCT02957097 -
Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures
|
Phase 4 | |
Completed |
NCT02565342 -
Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery
|
Phase 4 | |
Terminated |
NCT02599870 -
Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures
|
N/A | |
Completed |
NCT02380989 -
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain
|
Phase 2 | |
Completed |
NCT02984098 -
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
|
Phase 4 | |
Completed |
NCT03107338 -
Preventive Treatment of Pain After Dental Implant Surgery
|
Phase 4 | |
Completed |
NCT02489630 -
Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department
|
Phase 4 | |
Completed |
NCT02817477 -
Intranasal Ketamine for Acute Traumatic Pain
|
Phase 4 |